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FDA approves Vimpat for POS treatment in children with epilepsy
The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.
The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.
“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.
Find the full press release on the UCB website.
The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.
The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.
“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.
Find the full press release on the UCB website.
The Food and Drug Administration has approved lacosamide for the treatment of partial-onset seizures in children with epilepsy, according to a statement by UCB, manufacturer of the drug.
The approval by the FDA is an extension of the drug’s previous indication, which was approved in 2009 for use in adults, and is based on four clinical trials and pharmacokinetic analyses from adult and pediatric data. The expanded indication is for children older than 4 years, and applies only to the oral tablet. Lacosamide (Vimpat) injections remain indicated only for adult patients older than 17 years.
“Until recently there were few effective treatment options approved for childhood epilepsy. This has contributed to poor seizure control for many, which can be detrimental to overall quality of life. The availability of lacosamide for children with epilepsy has the potential to change the lives of children and their families by providing an additional choice to support them in their epilepsy journey,” Raman Sankar, MD, PhD, professor of neurology and pediatrics and chief of pediatric neurology at the University of California, Los Angeles, said in the statement.
Find the full press release on the UCB website.
ARDS incidence is declining. Is it a preventable syndrome?
TORONTO – The incidence of acute respiratory distress syndrome (ARDS) is on the decline, according to a retrospective, population-based cohort study conducted at the Mayo Clinic in Rochester, Minn.
“This is very promising data in combating this syndrome,” reported Augustin Joseph of the Mayo Clinic, and “it suggests that ARDS may in part be a completely preventable disease.”
To see if ARDS incidence has continued to decline, Mr. Joseph’s group studied all patients admitted during 2009-2014 to the Mayo Clinic’s ICU, the only facility in the county that cares for ARDS patients. From 82,388 ICU admissions, they identified 505 patients with ARDS according to the Berlin definition of ARDS developed in 2012.
The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.
Median age was 67 years in 2009 and 62 years in 2014. Hospital mortality ranged from 15% to 26% during the study period, while hospital length of stay ranged from 8 to 15 days, with no clear decline in either.
“For hospital and ICU mortality and hospital and ICU length of stay, we did not see much difference [from 2009 to 2014], so the overall picture between the Guangxi Li study and mine was that we did not see much of a difference in the patients who had ARDS, but [in terms of] preventing ARDS, the incidence has continued to decline,” Mr. Joseph reported.
While the earlier study used the American-European Consensus Conference (AECC) definition of ARDS, Mr. Joseph and his colleagues diagnosed ARDS according to the Berlin definition. One of the major changes seen in the new Berlin rules is that acute lung injury no longer exists and patients with a P/F ratio (PaO2/FiO2 ratio, or the ratio of arterial oxygen partial pressure to fractional inspired oxygen) between 200 and 300 are now considered to have “mild ARDS,” Mr. Joseph explained. With the AECC definition, a P/F ratio in this range was classified as acute lung injury and only one less than 200 was considered ARDS.
The researchers are now trying to parse out how changing ARDS diagnosis and management at their institution might be contributing to declining incidence, said Mr. Joseph.
TORONTO – The incidence of acute respiratory distress syndrome (ARDS) is on the decline, according to a retrospective, population-based cohort study conducted at the Mayo Clinic in Rochester, Minn.
“This is very promising data in combating this syndrome,” reported Augustin Joseph of the Mayo Clinic, and “it suggests that ARDS may in part be a completely preventable disease.”
To see if ARDS incidence has continued to decline, Mr. Joseph’s group studied all patients admitted during 2009-2014 to the Mayo Clinic’s ICU, the only facility in the county that cares for ARDS patients. From 82,388 ICU admissions, they identified 505 patients with ARDS according to the Berlin definition of ARDS developed in 2012.
The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.
Median age was 67 years in 2009 and 62 years in 2014. Hospital mortality ranged from 15% to 26% during the study period, while hospital length of stay ranged from 8 to 15 days, with no clear decline in either.
“For hospital and ICU mortality and hospital and ICU length of stay, we did not see much difference [from 2009 to 2014], so the overall picture between the Guangxi Li study and mine was that we did not see much of a difference in the patients who had ARDS, but [in terms of] preventing ARDS, the incidence has continued to decline,” Mr. Joseph reported.
While the earlier study used the American-European Consensus Conference (AECC) definition of ARDS, Mr. Joseph and his colleagues diagnosed ARDS according to the Berlin definition. One of the major changes seen in the new Berlin rules is that acute lung injury no longer exists and patients with a P/F ratio (PaO2/FiO2 ratio, or the ratio of arterial oxygen partial pressure to fractional inspired oxygen) between 200 and 300 are now considered to have “mild ARDS,” Mr. Joseph explained. With the AECC definition, a P/F ratio in this range was classified as acute lung injury and only one less than 200 was considered ARDS.
The researchers are now trying to parse out how changing ARDS diagnosis and management at their institution might be contributing to declining incidence, said Mr. Joseph.
TORONTO – The incidence of acute respiratory distress syndrome (ARDS) is on the decline, according to a retrospective, population-based cohort study conducted at the Mayo Clinic in Rochester, Minn.
“This is very promising data in combating this syndrome,” reported Augustin Joseph of the Mayo Clinic, and “it suggests that ARDS may in part be a completely preventable disease.”
To see if ARDS incidence has continued to decline, Mr. Joseph’s group studied all patients admitted during 2009-2014 to the Mayo Clinic’s ICU, the only facility in the county that cares for ARDS patients. From 82,388 ICU admissions, they identified 505 patients with ARDS according to the Berlin definition of ARDS developed in 2012.
The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.
Median age was 67 years in 2009 and 62 years in 2014. Hospital mortality ranged from 15% to 26% during the study period, while hospital length of stay ranged from 8 to 15 days, with no clear decline in either.
“For hospital and ICU mortality and hospital and ICU length of stay, we did not see much difference [from 2009 to 2014], so the overall picture between the Guangxi Li study and mine was that we did not see much of a difference in the patients who had ARDS, but [in terms of] preventing ARDS, the incidence has continued to decline,” Mr. Joseph reported.
While the earlier study used the American-European Consensus Conference (AECC) definition of ARDS, Mr. Joseph and his colleagues diagnosed ARDS according to the Berlin definition. One of the major changes seen in the new Berlin rules is that acute lung injury no longer exists and patients with a P/F ratio (PaO2/FiO2 ratio, or the ratio of arterial oxygen partial pressure to fractional inspired oxygen) between 200 and 300 are now considered to have “mild ARDS,” Mr. Joseph explained. With the AECC definition, a P/F ratio in this range was classified as acute lung injury and only one less than 200 was considered ARDS.
The researchers are now trying to parse out how changing ARDS diagnosis and management at their institution might be contributing to declining incidence, said Mr. Joseph.
AT CHEST 2017
Key clinical point: The incidence of acute respiratory distress syndrome is declining, an indication that it may be preventable, according to researchers.
Major finding: The number of annual cases dropped from 108 in 2009 to 59 in 2014, and the incidence steadily declined from 74.5 cases per 100,000 in 2009 to 39.3 per 100,000 in 2014.
Data source: Retrospective, population-based cohort study of all (505) patients admitted to the ICU for ARDS at a single center.
Disclosures: The authors reported having no relevant disclosures.
MACRA Monday: Documenting current medications
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
Measure #130: Documentation of Current Medications in the Medical Record
This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.
What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.
Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.
CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
- Those who enrolled in Medicare for the first time during a performance period.
- Those who have Medicare Part B allowed charges of $30,000 or less.
- Those who have 100 or fewer Medicare Part B patients.
- Those who are significantly participating in an Advanced Alternative Payment Model (APM).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
Measure #130: Documentation of Current Medications in the Medical Record
This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.
What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.
Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.
CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
- Those who enrolled in Medicare for the first time during a performance period.
- Those who have Medicare Part B allowed charges of $30,000 or less.
- Those who have 100 or fewer Medicare Part B patients.
- Those who are significantly participating in an Advanced Alternative Payment Model (APM).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.
Under the Pick Your Pace approach being offered this year, Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.
Consider this measure:
Measure #130: Documentation of Current Medications in the Medical Record
This measure is aimed at capturing the percentage of patients aged 18 years and older who had their current medications documented in the medical record, including nonprescription drugs, vitamins, and supplements.
What you need to do: Review and update the patient’s list of current medications, being sure to document all known prescriptions, over-the-counter medications, herbals, and vitamin/mineral/dietary supplements. This list must include the name, dosages, frequency, and route of administration for each drug.
Eligible cases include patients aged 18 years and older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 90791, 90792, 90832, 90834, 90837, 90839, 92002, 92004, 92012, 92014, 92507, 92508, 92526, 92537, 92538, 92540, 92541, 92542, 92544, 92545, 92547, 92548, 92550, 92557, 92567, 92568, 92570, 92585, 92588, 92626, 96116, 96150, 96151, 96152, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97532, 97802, 97803, 97804, 98960, 98961, 98962, 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99221, 99222, 99223, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, 99495, 99496, G0101, G0108, G0270, G0402, G0438, G0439.
To get credit under MIPS, be sure to include a QDC that shows that you successfully performed the measure or had a good reason for not doing so. For instance, G8427 indicates that the patient’s medical record was updated with the current medications. Use exception code G8430 if you documented in the medical record that the patient is not eligible for a current list of medications being obtained and reviewed.
CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.
Certain clinicians are exempt from reporting and do not face a penalty under MIPS:
- Those who enrolled in Medicare for the first time during a performance period.
- Those who have Medicare Part B allowed charges of $30,000 or less.
- Those who have 100 or fewer Medicare Part B patients.
- Those who are significantly participating in an Advanced Alternative Payment Model (APM).
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Incidental lung nodules are frequently not mentioned in hospital discharge summary
Clinical question: How often are incidentally found pulmonary nodules and instructions for follow-up included in the discharge summary?
Background: Lung nodules are frequent incidental findings on imaging, but it is unclear whether patients are subsequently receiving the recommended follow-up.
Study design: Retrospective cohort study.
Synopsis: The authors identified 7,173 patients who had undergone abdominal CT scans during their admission and reviewed charts of 402 patients who had incidentally found pulmonary nodules identified on the scans. For each of the patients, discharge summaries were evaluated to determine whether they made reference to the nodules and whether follow-up instructions were included. Of the 208 patients noted to have nodules requiring follow-up, only 48 (23%) had discharge summaries that mentioned the nodules. Factors associated with including the nodules in the discharge summary were the radiologist recommending further surveillance, radiologist including the nodule in the summary heading of the report, and being on a medical as opposed to a surgical service. The authors concluded that systems-based approaches to incidentally found lung nodules are needed to ensure adequate follow-up.
Bottom line: Incidentally found lung nodules are often not included in discharge documentation and therefore may not receive the recommended follow-up.
Citation: Bates R, Plooster C, Croghan I, et al. Incidental pulmonary nodules reported on CT abdominal imaging: Frequency and factors affecting inclusion in the hospital discharge summary. J Hosp Med. 2017;6:454-7.
Dr. Herscher is assistant professor, division of hospital medicine, Icahn School of Medicine of the Mount Sinai Health System.
Clinical question: How often are incidentally found pulmonary nodules and instructions for follow-up included in the discharge summary?
Background: Lung nodules are frequent incidental findings on imaging, but it is unclear whether patients are subsequently receiving the recommended follow-up.
Study design: Retrospective cohort study.
Synopsis: The authors identified 7,173 patients who had undergone abdominal CT scans during their admission and reviewed charts of 402 patients who had incidentally found pulmonary nodules identified on the scans. For each of the patients, discharge summaries were evaluated to determine whether they made reference to the nodules and whether follow-up instructions were included. Of the 208 patients noted to have nodules requiring follow-up, only 48 (23%) had discharge summaries that mentioned the nodules. Factors associated with including the nodules in the discharge summary were the radiologist recommending further surveillance, radiologist including the nodule in the summary heading of the report, and being on a medical as opposed to a surgical service. The authors concluded that systems-based approaches to incidentally found lung nodules are needed to ensure adequate follow-up.
Bottom line: Incidentally found lung nodules are often not included in discharge documentation and therefore may not receive the recommended follow-up.
Citation: Bates R, Plooster C, Croghan I, et al. Incidental pulmonary nodules reported on CT abdominal imaging: Frequency and factors affecting inclusion in the hospital discharge summary. J Hosp Med. 2017;6:454-7.
Dr. Herscher is assistant professor, division of hospital medicine, Icahn School of Medicine of the Mount Sinai Health System.
Clinical question: How often are incidentally found pulmonary nodules and instructions for follow-up included in the discharge summary?
Background: Lung nodules are frequent incidental findings on imaging, but it is unclear whether patients are subsequently receiving the recommended follow-up.
Study design: Retrospective cohort study.
Synopsis: The authors identified 7,173 patients who had undergone abdominal CT scans during their admission and reviewed charts of 402 patients who had incidentally found pulmonary nodules identified on the scans. For each of the patients, discharge summaries were evaluated to determine whether they made reference to the nodules and whether follow-up instructions were included. Of the 208 patients noted to have nodules requiring follow-up, only 48 (23%) had discharge summaries that mentioned the nodules. Factors associated with including the nodules in the discharge summary were the radiologist recommending further surveillance, radiologist including the nodule in the summary heading of the report, and being on a medical as opposed to a surgical service. The authors concluded that systems-based approaches to incidentally found lung nodules are needed to ensure adequate follow-up.
Bottom line: Incidentally found lung nodules are often not included in discharge documentation and therefore may not receive the recommended follow-up.
Citation: Bates R, Plooster C, Croghan I, et al. Incidental pulmonary nodules reported on CT abdominal imaging: Frequency and factors affecting inclusion in the hospital discharge summary. J Hosp Med. 2017;6:454-7.
Dr. Herscher is assistant professor, division of hospital medicine, Icahn School of Medicine of the Mount Sinai Health System.
Results support using MTD of HU in kids with SCA
Dosing of hydroxyurea (HU) in young patients with sickle cell anemia (SCA) should target a fetal hemoglobin (HbF) level above 20%, according to researchers.
Their study, HUSTLE, showed that children and adolescents who received a maximum tolerated dose (MTD) of HU were able to achieve HbF levels above 20%.
And patients who achieved such HbF levels had a significantly lower risk of hospitalization for any reason, including vaso-occlusive crisis, acute chest syndrome, and fever.
Jeremie Estepp, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues reported these results in the American Journal of Hematology.
“Our analysis showed that, using this approach, hospitalizations for the average patient fell to less than 1 every couple of years rather than 4 to 6 annually,” Dr Estepp said. “This frees children from the fevers, pain, and other symptoms of this disease and gives them and their families more chances to enjoy childhood and adolescence.”
The study enrolled 230 SCA patients. Most had the HbSS genotype (n=214; 93%), although 7% (n=16) had HbSb0 thalassemia. The patients’ median age at HU initiation was 7.4 years (range, 6 months to 17.9 years). The mean HbF level at enrollment was 9.7%, and the median was 7.9% (range, 1.0-32.9%).
The researchers used a dose-escalation approach to determine the MTD of HU for each of the patients in this study. The MTD was defined by an absolute neutrophil count of 2000-4000 x 106/L or the presence of hematologic toxicity. The maximum absolute dose was 35 mg/kg/day or 2000 mg/day (whichever came first).
The mean daily dose of HU at the MTD was 26.7 mg/kg/day, and the median was 28.0 mg/kg/day (range, 13.0 to 35.0 mg/kg/day).
Three-quarters of patients (75.2%, 173/230) attained the MTD at the time of data censoring. Patients were followed for up to 4 years after study entry.
As far as treatment compliance, there were complete medication dispensation records available for 96% (220/230) of patients. And the patients were in possession of HU a mean of 93.6% of the time.
The researchers found that administering HU at the MTD resulted in a mean HbF of 26.7% and a median of 21.7% (interquartile range, 16.2% to 27.8%).
And the odds of being hospitalized were higher when a patient’s HbF level was less than 21%. The odds ratios for hospitalization were as follows:
- 4.1 for fever
- 2.6 for acute chest syndrome
- 2.2 for vaso-occlusive crisis
- 2.1 for any reason.
“These results support a hydroxyurea dosing strategy designed to produce fetal hemoglobin levels that exceed 20% in an effort to decrease hospitalization of children with sickle cell disease,” Dr Estepp said.
He and his colleagues are now conducting a multicenter trial to determine if toddlers with SCA would benefit from a similar dosing strategy or would respond better to a standard dose. 
Dosing of hydroxyurea (HU) in young patients with sickle cell anemia (SCA) should target a fetal hemoglobin (HbF) level above 20%, according to researchers.
Their study, HUSTLE, showed that children and adolescents who received a maximum tolerated dose (MTD) of HU were able to achieve HbF levels above 20%.
And patients who achieved such HbF levels had a significantly lower risk of hospitalization for any reason, including vaso-occlusive crisis, acute chest syndrome, and fever.
Jeremie Estepp, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues reported these results in the American Journal of Hematology.
“Our analysis showed that, using this approach, hospitalizations for the average patient fell to less than 1 every couple of years rather than 4 to 6 annually,” Dr Estepp said. “This frees children from the fevers, pain, and other symptoms of this disease and gives them and their families more chances to enjoy childhood and adolescence.”
The study enrolled 230 SCA patients. Most had the HbSS genotype (n=214; 93%), although 7% (n=16) had HbSb0 thalassemia. The patients’ median age at HU initiation was 7.4 years (range, 6 months to 17.9 years). The mean HbF level at enrollment was 9.7%, and the median was 7.9% (range, 1.0-32.9%).
The researchers used a dose-escalation approach to determine the MTD of HU for each of the patients in this study. The MTD was defined by an absolute neutrophil count of 2000-4000 x 106/L or the presence of hematologic toxicity. The maximum absolute dose was 35 mg/kg/day or 2000 mg/day (whichever came first).
The mean daily dose of HU at the MTD was 26.7 mg/kg/day, and the median was 28.0 mg/kg/day (range, 13.0 to 35.0 mg/kg/day).
Three-quarters of patients (75.2%, 173/230) attained the MTD at the time of data censoring. Patients were followed for up to 4 years after study entry.
As far as treatment compliance, there were complete medication dispensation records available for 96% (220/230) of patients. And the patients were in possession of HU a mean of 93.6% of the time.
The researchers found that administering HU at the MTD resulted in a mean HbF of 26.7% and a median of 21.7% (interquartile range, 16.2% to 27.8%).
And the odds of being hospitalized were higher when a patient’s HbF level was less than 21%. The odds ratios for hospitalization were as follows:
- 4.1 for fever
- 2.6 for acute chest syndrome
- 2.2 for vaso-occlusive crisis
- 2.1 for any reason.
“These results support a hydroxyurea dosing strategy designed to produce fetal hemoglobin levels that exceed 20% in an effort to decrease hospitalization of children with sickle cell disease,” Dr Estepp said.
He and his colleagues are now conducting a multicenter trial to determine if toddlers with SCA would benefit from a similar dosing strategy or would respond better to a standard dose.
Dosing of hydroxyurea (HU) in young patients with sickle cell anemia (SCA) should target a fetal hemoglobin (HbF) level above 20%, according to researchers.
Their study, HUSTLE, showed that children and adolescents who received a maximum tolerated dose (MTD) of HU were able to achieve HbF levels above 20%.
And patients who achieved such HbF levels had a significantly lower risk of hospitalization for any reason, including vaso-occlusive crisis, acute chest syndrome, and fever.
Jeremie Estepp, MD, of St. Jude Children’s Research Hospital in Memphis, Tennessee, and his colleagues reported these results in the American Journal of Hematology.
“Our analysis showed that, using this approach, hospitalizations for the average patient fell to less than 1 every couple of years rather than 4 to 6 annually,” Dr Estepp said. “This frees children from the fevers, pain, and other symptoms of this disease and gives them and their families more chances to enjoy childhood and adolescence.”
The study enrolled 230 SCA patients. Most had the HbSS genotype (n=214; 93%), although 7% (n=16) had HbSb0 thalassemia. The patients’ median age at HU initiation was 7.4 years (range, 6 months to 17.9 years). The mean HbF level at enrollment was 9.7%, and the median was 7.9% (range, 1.0-32.9%).
The researchers used a dose-escalation approach to determine the MTD of HU for each of the patients in this study. The MTD was defined by an absolute neutrophil count of 2000-4000 x 106/L or the presence of hematologic toxicity. The maximum absolute dose was 35 mg/kg/day or 2000 mg/day (whichever came first).
The mean daily dose of HU at the MTD was 26.7 mg/kg/day, and the median was 28.0 mg/kg/day (range, 13.0 to 35.0 mg/kg/day).
Three-quarters of patients (75.2%, 173/230) attained the MTD at the time of data censoring. Patients were followed for up to 4 years after study entry.
As far as treatment compliance, there were complete medication dispensation records available for 96% (220/230) of patients. And the patients were in possession of HU a mean of 93.6% of the time.
The researchers found that administering HU at the MTD resulted in a mean HbF of 26.7% and a median of 21.7% (interquartile range, 16.2% to 27.8%).
And the odds of being hospitalized were higher when a patient’s HbF level was less than 21%. The odds ratios for hospitalization were as follows:
- 4.1 for fever
- 2.6 for acute chest syndrome
- 2.2 for vaso-occlusive crisis
- 2.1 for any reason.
“These results support a hydroxyurea dosing strategy designed to produce fetal hemoglobin levels that exceed 20% in an effort to decrease hospitalization of children with sickle cell disease,” Dr Estepp said.
He and his colleagues are now conducting a multicenter trial to determine if toddlers with SCA would benefit from a similar dosing strategy or would respond better to a standard dose.
Tick, Tick, Boom
1. A 16-year-old boy presents with a skin ulcer on the dorsum of his hand and swollen glands in the proximal axilla. He works as a camp counselor in South Dakota, leading nature walks and teaching the children to care for animals, including the camp’s rabbits. Several weeks ago, he developed a fever of 103°F, fatigue, and body aches, followed by the appearance of the skin lesion.
Diagnosis: Tularemia—also called rabbit fever or deer fly fever—is caused by the bacterium Francisella tularensis. It is an insect-borne pathogen of rabbits, squirrels, and other rodents, most commonly found in the western United States and Russia. Symptoms vary by mechanism of exposure but include skin ulcers; irritation and inflammation of the eye; sore throat, mouth ulcers, and tonsillitis; lung involvement with cough, chest pain, and difficulty breathing; and swelling of regional lymph nodes. Tularemia can be successfully treated with antibiotics.
For more information, see “Pneumonic Tularemia Presenting With a Vesicular Eruption.” Cutis. 2015;95(4):E17-E18.
2. About 10-12 days after hiking in the Appalachian Mountains, this young woman presents with a 7-in circular rash on her upper back that is slightly warm to the touch. She denies fever, pruritus, and joint pain.
Diagnosis: Lyme disease is the most common tick-borne illness in the United States, with more than 25,000 confirmed cases in 2014. It is concentrated mostly in the northeast and upper Midwest, although in 2014, only five states (Colorado, Hawaii, Louisiana, New Mexico, and Oklahoma) reported no incidence. Lyme disease is caused by Borrelia burgdorferi, which is transmitted to humans by the Ixodes tick.
For more information, see “Beyond the bull's eye: Recognizing Lyme disease.” J Fam Pract. 2016;65(6):373-379.
3. A 42-year-old Native American farmer in Arizona has a reddish purple petechial rash on his ankles and feet. Upon questioning, he reports that about three weeks ago he had a slight fever with headache and malaise. Then, last week, he noticed small, flat, pink, nonitchy macules on his wrists, forearms, and ankles; they are now spreading to the trunk.
Source: CDC
[https://www.cdc.gov/rmsf/symptoms/index.html]
Diagnosis: Rocky Mountain spotted fever, now reported to the CDC as spotted fever rickettsiosis, is a tick-borne illness caused by the gram-negative intracellular bacterium Rickettsia rickettsia. It is endemic in the Southeastern and South Central United States. Most cases occur between April and September, coinciding with the active season of the vector tick species. Early diagnosis is critical because untreated RMSF may progress to fulminant systemic illness.
For more information, see “Fever and Rash in a 3-Year-Old Girl: Rocky Mountain Spotted Fever.” Cutis. 2002;70(3):165-168.
1. A 16-year-old boy presents with a skin ulcer on the dorsum of his hand and swollen glands in the proximal axilla. He works as a camp counselor in South Dakota, leading nature walks and teaching the children to care for animals, including the camp’s rabbits. Several weeks ago, he developed a fever of 103°F, fatigue, and body aches, followed by the appearance of the skin lesion.
Diagnosis: Tularemia—also called rabbit fever or deer fly fever—is caused by the bacterium Francisella tularensis. It is an insect-borne pathogen of rabbits, squirrels, and other rodents, most commonly found in the western United States and Russia. Symptoms vary by mechanism of exposure but include skin ulcers; irritation and inflammation of the eye; sore throat, mouth ulcers, and tonsillitis; lung involvement with cough, chest pain, and difficulty breathing; and swelling of regional lymph nodes. Tularemia can be successfully treated with antibiotics.
For more information, see “Pneumonic Tularemia Presenting With a Vesicular Eruption.” Cutis. 2015;95(4):E17-E18.
2. About 10-12 days after hiking in the Appalachian Mountains, this young woman presents with a 7-in circular rash on her upper back that is slightly warm to the touch. She denies fever, pruritus, and joint pain.
Diagnosis: Lyme disease is the most common tick-borne illness in the United States, with more than 25,000 confirmed cases in 2014. It is concentrated mostly in the northeast and upper Midwest, although in 2014, only five states (Colorado, Hawaii, Louisiana, New Mexico, and Oklahoma) reported no incidence. Lyme disease is caused by Borrelia burgdorferi, which is transmitted to humans by the Ixodes tick.
For more information, see “Beyond the bull's eye: Recognizing Lyme disease.” J Fam Pract. 2016;65(6):373-379.
3. A 42-year-old Native American farmer in Arizona has a reddish purple petechial rash on his ankles and feet. Upon questioning, he reports that about three weeks ago he had a slight fever with headache and malaise. Then, last week, he noticed small, flat, pink, nonitchy macules on his wrists, forearms, and ankles; they are now spreading to the trunk.
Source: CDC
[https://www.cdc.gov/rmsf/symptoms/index.html]
Diagnosis: Rocky Mountain spotted fever, now reported to the CDC as spotted fever rickettsiosis, is a tick-borne illness caused by the gram-negative intracellular bacterium Rickettsia rickettsia. It is endemic in the Southeastern and South Central United States. Most cases occur between April and September, coinciding with the active season of the vector tick species. Early diagnosis is critical because untreated RMSF may progress to fulminant systemic illness.
For more information, see “Fever and Rash in a 3-Year-Old Girl: Rocky Mountain Spotted Fever.” Cutis. 2002;70(3):165-168.
1. A 16-year-old boy presents with a skin ulcer on the dorsum of his hand and swollen glands in the proximal axilla. He works as a camp counselor in South Dakota, leading nature walks and teaching the children to care for animals, including the camp’s rabbits. Several weeks ago, he developed a fever of 103°F, fatigue, and body aches, followed by the appearance of the skin lesion.
Diagnosis: Tularemia—also called rabbit fever or deer fly fever—is caused by the bacterium Francisella tularensis. It is an insect-borne pathogen of rabbits, squirrels, and other rodents, most commonly found in the western United States and Russia. Symptoms vary by mechanism of exposure but include skin ulcers; irritation and inflammation of the eye; sore throat, mouth ulcers, and tonsillitis; lung involvement with cough, chest pain, and difficulty breathing; and swelling of regional lymph nodes. Tularemia can be successfully treated with antibiotics.
For more information, see “Pneumonic Tularemia Presenting With a Vesicular Eruption.” Cutis. 2015;95(4):E17-E18.
2. About 10-12 days after hiking in the Appalachian Mountains, this young woman presents with a 7-in circular rash on her upper back that is slightly warm to the touch. She denies fever, pruritus, and joint pain.
Diagnosis: Lyme disease is the most common tick-borne illness in the United States, with more than 25,000 confirmed cases in 2014. It is concentrated mostly in the northeast and upper Midwest, although in 2014, only five states (Colorado, Hawaii, Louisiana, New Mexico, and Oklahoma) reported no incidence. Lyme disease is caused by Borrelia burgdorferi, which is transmitted to humans by the Ixodes tick.
For more information, see “Beyond the bull's eye: Recognizing Lyme disease.” J Fam Pract. 2016;65(6):373-379.
3. A 42-year-old Native American farmer in Arizona has a reddish purple petechial rash on his ankles and feet. Upon questioning, he reports that about three weeks ago he had a slight fever with headache and malaise. Then, last week, he noticed small, flat, pink, nonitchy macules on his wrists, forearms, and ankles; they are now spreading to the trunk.
Source: CDC
[https://www.cdc.gov/rmsf/symptoms/index.html]
Diagnosis: Rocky Mountain spotted fever, now reported to the CDC as spotted fever rickettsiosis, is a tick-borne illness caused by the gram-negative intracellular bacterium Rickettsia rickettsia. It is endemic in the Southeastern and South Central United States. Most cases occur between April and September, coinciding with the active season of the vector tick species. Early diagnosis is critical because untreated RMSF may progress to fulminant systemic illness.
For more information, see “Fever and Rash in a 3-Year-Old Girl: Rocky Mountain Spotted Fever.” Cutis. 2002;70(3):165-168.
VIDEO: ERAS for minimally invasive surgery
Stacy A. Brethauer, MD, FACS, discusses the role of Enhanced Recovery After Surgery (ERAS) in minimally invasive surgical procedures. The goal of the ERAS approach is to minimize surgical stress on the patient, reduce length of stay, and reduce the use of opioids in the recovery phase. Dr. Brethauer discusses a pilot program, the Energy project, which will be conducted in more than 30 institutions for a year to look at an ERAS protocol designed to work with minimally invasive surgical procedures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Stacy A. Brethauer, MD, FACS, discusses the role of Enhanced Recovery After Surgery (ERAS) in minimally invasive surgical procedures. The goal of the ERAS approach is to minimize surgical stress on the patient, reduce length of stay, and reduce the use of opioids in the recovery phase. Dr. Brethauer discusses a pilot program, the Energy project, which will be conducted in more than 30 institutions for a year to look at an ERAS protocol designed to work with minimally invasive surgical procedures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Stacy A. Brethauer, MD, FACS, discusses the role of Enhanced Recovery After Surgery (ERAS) in minimally invasive surgical procedures. The goal of the ERAS approach is to minimize surgical stress on the patient, reduce length of stay, and reduce the use of opioids in the recovery phase. Dr. Brethauer discusses a pilot program, the Energy project, which will be conducted in more than 30 institutions for a year to look at an ERAS protocol designed to work with minimally invasive surgical procedures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Blindness linked to HCQ use rare in rheumatic patients
SAN DIEGO – Out of a cohort of nearly 2,900 rheumatic patients, none developed blindness attributable to toxic maculopathy from using hydroxychloroquine, in a single-center retrospective study.
“That’s very reassuring,” lead study author Dilpreet K. Singh, MD, said in an interview at the annual meeting of the American College of Rheumatology. “It’s still important to be vigilant with our screening and also to take note of the hydroxychloroquine dose that they’re on, because a lot of our patients have been on hydroxychloroquine for 10 or 15 years and there may not have been a dose adjustment. It’s also important to focus on the patients’ comorbidities and get them under better control.”
In an effort to assess the prevalence of blindness in a cohort of rheumatic patients and to identify the characteristics and comorbidities of those with HCQ retinal toxicity, Dr. Singh and her associates retrospectively evaluated 2,898 patients at MetroHealth Medical Center between January 1999 and August of 2017 with diagnoses of rheumatoid arthritis, inflammatory polyarthritis, systemic lupus erythematosus, subacute cutaneous lupus, and discoid lupus erythematosus who had a prescription written for HCQ.
In all, 31 had a diagnosis of “blindness” or “toxic maculopathy,” and these cases were further assessed for patient demographics, comorbidities, use of tamoxifen, weight and dose at initiation and discontinuation of HCQ, and duration of HCQ. Nearly 70% of these patients had hypertension, about 60% had chronic kidney disease, and 35% had cataracts. The researchers confirmed that in each of the cases the blindness was not caused by HCQ ocular toxicity, but instead by stroke, preexisting macular disease, diabetic retinopathy, hypertensive retinopathy, or cataracts.
Only 3 of the 31 patients were found to have HCQ retinal toxicity, each without blindness or change in vision. Two patients had bull’s-eye maculopathy and one had HCQ toxic maculopathy. Each of the three patients had received HCQ for more than 18 years at doses that ranged from 6.3 to 8.2 mg/kg based on documented weight, and none had functional vision loss at diagnosis.
“It’s reassuring to know that there’s a very small percentage of patients that will have HCQ-related toxicity,” Dr. Singh concluded. “We should also be focusing on the comorbidities [such as] diabetes, hypertension, and stroke-related vision loss that are common in our population of rheumatic patients, because these are contributing to visual impairment and blindness.”
She reported having no disclosures.
[email protected]
SAN DIEGO – Out of a cohort of nearly 2,900 rheumatic patients, none developed blindness attributable to toxic maculopathy from using hydroxychloroquine, in a single-center retrospective study.
“That’s very reassuring,” lead study author Dilpreet K. Singh, MD, said in an interview at the annual meeting of the American College of Rheumatology. “It’s still important to be vigilant with our screening and also to take note of the hydroxychloroquine dose that they’re on, because a lot of our patients have been on hydroxychloroquine for 10 or 15 years and there may not have been a dose adjustment. It’s also important to focus on the patients’ comorbidities and get them under better control.”
In an effort to assess the prevalence of blindness in a cohort of rheumatic patients and to identify the characteristics and comorbidities of those with HCQ retinal toxicity, Dr. Singh and her associates retrospectively evaluated 2,898 patients at MetroHealth Medical Center between January 1999 and August of 2017 with diagnoses of rheumatoid arthritis, inflammatory polyarthritis, systemic lupus erythematosus, subacute cutaneous lupus, and discoid lupus erythematosus who had a prescription written for HCQ.
In all, 31 had a diagnosis of “blindness” or “toxic maculopathy,” and these cases were further assessed for patient demographics, comorbidities, use of tamoxifen, weight and dose at initiation and discontinuation of HCQ, and duration of HCQ. Nearly 70% of these patients had hypertension, about 60% had chronic kidney disease, and 35% had cataracts. The researchers confirmed that in each of the cases the blindness was not caused by HCQ ocular toxicity, but instead by stroke, preexisting macular disease, diabetic retinopathy, hypertensive retinopathy, or cataracts.
Only 3 of the 31 patients were found to have HCQ retinal toxicity, each without blindness or change in vision. Two patients had bull’s-eye maculopathy and one had HCQ toxic maculopathy. Each of the three patients had received HCQ for more than 18 years at doses that ranged from 6.3 to 8.2 mg/kg based on documented weight, and none had functional vision loss at diagnosis.
“It’s reassuring to know that there’s a very small percentage of patients that will have HCQ-related toxicity,” Dr. Singh concluded. “We should also be focusing on the comorbidities [such as] diabetes, hypertension, and stroke-related vision loss that are common in our population of rheumatic patients, because these are contributing to visual impairment and blindness.”
She reported having no disclosures.
[email protected]
SAN DIEGO – Out of a cohort of nearly 2,900 rheumatic patients, none developed blindness attributable to toxic maculopathy from using hydroxychloroquine, in a single-center retrospective study.
“That’s very reassuring,” lead study author Dilpreet K. Singh, MD, said in an interview at the annual meeting of the American College of Rheumatology. “It’s still important to be vigilant with our screening and also to take note of the hydroxychloroquine dose that they’re on, because a lot of our patients have been on hydroxychloroquine for 10 or 15 years and there may not have been a dose adjustment. It’s also important to focus on the patients’ comorbidities and get them under better control.”
In an effort to assess the prevalence of blindness in a cohort of rheumatic patients and to identify the characteristics and comorbidities of those with HCQ retinal toxicity, Dr. Singh and her associates retrospectively evaluated 2,898 patients at MetroHealth Medical Center between January 1999 and August of 2017 with diagnoses of rheumatoid arthritis, inflammatory polyarthritis, systemic lupus erythematosus, subacute cutaneous lupus, and discoid lupus erythematosus who had a prescription written for HCQ.
In all, 31 had a diagnosis of “blindness” or “toxic maculopathy,” and these cases were further assessed for patient demographics, comorbidities, use of tamoxifen, weight and dose at initiation and discontinuation of HCQ, and duration of HCQ. Nearly 70% of these patients had hypertension, about 60% had chronic kidney disease, and 35% had cataracts. The researchers confirmed that in each of the cases the blindness was not caused by HCQ ocular toxicity, but instead by stroke, preexisting macular disease, diabetic retinopathy, hypertensive retinopathy, or cataracts.
Only 3 of the 31 patients were found to have HCQ retinal toxicity, each without blindness or change in vision. Two patients had bull’s-eye maculopathy and one had HCQ toxic maculopathy. Each of the three patients had received HCQ for more than 18 years at doses that ranged from 6.3 to 8.2 mg/kg based on documented weight, and none had functional vision loss at diagnosis.
“It’s reassuring to know that there’s a very small percentage of patients that will have HCQ-related toxicity,” Dr. Singh concluded. “We should also be focusing on the comorbidities [such as] diabetes, hypertension, and stroke-related vision loss that are common in our population of rheumatic patients, because these are contributing to visual impairment and blindness.”
She reported having no disclosures.
[email protected]
AT ACR 2017
Key clinical point: The incidence of blindness due to hydroxychloroquine toxicity is very low.
Major finding: No patients developed blindness attributable to toxic maculopathy from using hydroxychloroquine.
Study details: A single-center retrospective study of 2,898 rheumatic patients.
Disclosures: Dr. Singh reported having no disclosures.
TAP an alternative to epidural for colorectal surgery
SCOTTSDALE, ARIZ. – In colorectal surgery, transversus abdominis plane (TAP) block was associated with shorter hospital stays than epidural, according to a study that was conducted in patients undergoing both open and laparoscopic surgeries. TAP fared well in both groups.
There were higher rates of nausea/vomiting in the TAP group, suggesting the need for preoperative management in patients preparing to undergo TAP block. Urine retention was higher in the epidural group.
Physicians used liposomal bupivacaine, which is more costly than alternatives, and that fact met some resistance in the audience when the study was presented at the annual meeting of the Western Surgical Association. But patients receiving TAP had a 0.5-day shorter length of stay, which should reduce costs overall, and the drug component cost of TAP was less than $100 more than for the epidural.
“The biggest conclusion we drew from this study was that in patients where you would always consider an epidural historically, like an open procedure or a laparoscopic procedure where the conversion risk to open was higher, [favoring epidural] is now being called into question. We really believe that TAP block affords the length of stay benefit with no change in the pain control regimen after surgery,” Shawn Obi, DO, chief of surgery at Henry Ford Allegiance Health, Jackson, Mich., said in an interview.
The findings dovetail with an overall trend of improved protocols in colon surgery. “I think we’re working toward colorectal surgery as an outpatient operation, similar to what has happened in the joint arena,” said Dr. Obi.
His colleague, Matt Torgeson, DO, who is a surgical resident at Henry Ford Allegiance Health, noted that the hospital stay following colorectal surgery was once 6-8 days, and it has been shortened to 3-3.5 days. Enhanced recovery protocols made the biggest impact, shaving about 3 days. “Now we’re going to be seeing small, incremental changes,” said Dr. Torgeson.
The researchers randomized patients undergoing open or laparoscopic colorectal surgery to receive either an epidural (n = 37) or TAP block (n = 41). All patients entered an enhanced recovery pathway following surgery, with standardized discharge criteria. The two groups had similar times to return to normal bowel function (TAP, 1.7 days; epidural, 1.9 days) but the length of hospital stay was lower in the TAP group (2.8 days vs. 3.3 days; P = .023; 74.9 hours vs. 86.3 hours; P = .045). Subjects in the epidural group had a higher frequency of urinary retention (29.7% vs. 14.6%), though this did not reach statistical significance (P = .11). Postoperative nausea occurred at a higher rate in the TAP group (31.7% vs. 13.5%; odds ratio, 2.97), though this result just missed significance (P = .06).
In patients who had open surgery or laparoscopic surgery that converted to open, the length of stay was 2.9 days in the TAP group (n = 9) and 4.4 days in the epidural group (n = 5). Those numbers are small, but they suggest that TAP is effective even in open surgery. The cost of TAP was about $80 more than epidural medication ($406.16 vs. $322.73).
The study received no outside funding. Dr. Torgeson and Dr. Obi reported having no financial disclosures.
SCOTTSDALE, ARIZ. – In colorectal surgery, transversus abdominis plane (TAP) block was associated with shorter hospital stays than epidural, according to a study that was conducted in patients undergoing both open and laparoscopic surgeries. TAP fared well in both groups.
There were higher rates of nausea/vomiting in the TAP group, suggesting the need for preoperative management in patients preparing to undergo TAP block. Urine retention was higher in the epidural group.
Physicians used liposomal bupivacaine, which is more costly than alternatives, and that fact met some resistance in the audience when the study was presented at the annual meeting of the Western Surgical Association. But patients receiving TAP had a 0.5-day shorter length of stay, which should reduce costs overall, and the drug component cost of TAP was less than $100 more than for the epidural.
“The biggest conclusion we drew from this study was that in patients where you would always consider an epidural historically, like an open procedure or a laparoscopic procedure where the conversion risk to open was higher, [favoring epidural] is now being called into question. We really believe that TAP block affords the length of stay benefit with no change in the pain control regimen after surgery,” Shawn Obi, DO, chief of surgery at Henry Ford Allegiance Health, Jackson, Mich., said in an interview.
The findings dovetail with an overall trend of improved protocols in colon surgery. “I think we’re working toward colorectal surgery as an outpatient operation, similar to what has happened in the joint arena,” said Dr. Obi.
His colleague, Matt Torgeson, DO, who is a surgical resident at Henry Ford Allegiance Health, noted that the hospital stay following colorectal surgery was once 6-8 days, and it has been shortened to 3-3.5 days. Enhanced recovery protocols made the biggest impact, shaving about 3 days. “Now we’re going to be seeing small, incremental changes,” said Dr. Torgeson.
The researchers randomized patients undergoing open or laparoscopic colorectal surgery to receive either an epidural (n = 37) or TAP block (n = 41). All patients entered an enhanced recovery pathway following surgery, with standardized discharge criteria. The two groups had similar times to return to normal bowel function (TAP, 1.7 days; epidural, 1.9 days) but the length of hospital stay was lower in the TAP group (2.8 days vs. 3.3 days; P = .023; 74.9 hours vs. 86.3 hours; P = .045). Subjects in the epidural group had a higher frequency of urinary retention (29.7% vs. 14.6%), though this did not reach statistical significance (P = .11). Postoperative nausea occurred at a higher rate in the TAP group (31.7% vs. 13.5%; odds ratio, 2.97), though this result just missed significance (P = .06).
In patients who had open surgery or laparoscopic surgery that converted to open, the length of stay was 2.9 days in the TAP group (n = 9) and 4.4 days in the epidural group (n = 5). Those numbers are small, but they suggest that TAP is effective even in open surgery. The cost of TAP was about $80 more than epidural medication ($406.16 vs. $322.73).
The study received no outside funding. Dr. Torgeson and Dr. Obi reported having no financial disclosures.
SCOTTSDALE, ARIZ. – In colorectal surgery, transversus abdominis plane (TAP) block was associated with shorter hospital stays than epidural, according to a study that was conducted in patients undergoing both open and laparoscopic surgeries. TAP fared well in both groups.
There were higher rates of nausea/vomiting in the TAP group, suggesting the need for preoperative management in patients preparing to undergo TAP block. Urine retention was higher in the epidural group.
Physicians used liposomal bupivacaine, which is more costly than alternatives, and that fact met some resistance in the audience when the study was presented at the annual meeting of the Western Surgical Association. But patients receiving TAP had a 0.5-day shorter length of stay, which should reduce costs overall, and the drug component cost of TAP was less than $100 more than for the epidural.
“The biggest conclusion we drew from this study was that in patients where you would always consider an epidural historically, like an open procedure or a laparoscopic procedure where the conversion risk to open was higher, [favoring epidural] is now being called into question. We really believe that TAP block affords the length of stay benefit with no change in the pain control regimen after surgery,” Shawn Obi, DO, chief of surgery at Henry Ford Allegiance Health, Jackson, Mich., said in an interview.
The findings dovetail with an overall trend of improved protocols in colon surgery. “I think we’re working toward colorectal surgery as an outpatient operation, similar to what has happened in the joint arena,” said Dr. Obi.
His colleague, Matt Torgeson, DO, who is a surgical resident at Henry Ford Allegiance Health, noted that the hospital stay following colorectal surgery was once 6-8 days, and it has been shortened to 3-3.5 days. Enhanced recovery protocols made the biggest impact, shaving about 3 days. “Now we’re going to be seeing small, incremental changes,” said Dr. Torgeson.
The researchers randomized patients undergoing open or laparoscopic colorectal surgery to receive either an epidural (n = 37) or TAP block (n = 41). All patients entered an enhanced recovery pathway following surgery, with standardized discharge criteria. The two groups had similar times to return to normal bowel function (TAP, 1.7 days; epidural, 1.9 days) but the length of hospital stay was lower in the TAP group (2.8 days vs. 3.3 days; P = .023; 74.9 hours vs. 86.3 hours; P = .045). Subjects in the epidural group had a higher frequency of urinary retention (29.7% vs. 14.6%), though this did not reach statistical significance (P = .11). Postoperative nausea occurred at a higher rate in the TAP group (31.7% vs. 13.5%; odds ratio, 2.97), though this result just missed significance (P = .06).
In patients who had open surgery or laparoscopic surgery that converted to open, the length of stay was 2.9 days in the TAP group (n = 9) and 4.4 days in the epidural group (n = 5). Those numbers are small, but they suggest that TAP is effective even in open surgery. The cost of TAP was about $80 more than epidural medication ($406.16 vs. $322.73).
The study received no outside funding. Dr. Torgeson and Dr. Obi reported having no financial disclosures.
AT WSA 2017
Key clinical point: In appropriately selected patients, TAP may be a good alternative to epidural.
Major finding: TAP block was associated with a 0.5-day shorter hospital stay than epidurals.
Data source: Randomized, controlled trial (n = 78).
Disclosures: The study received no outside funding. Dr. Torgeson and Dr. Obi reported having no financial disclosures.
Acute cholecystitis guidelines need work
SCOTTSDALE, ARIZ. – In patients with right upper quadrant pain, the Tokyo Guidelines (TG13) failed to detect acute cholecystitis with adequate sensitivity, according to a single institution retrospective review.
Researchers at the University of Arizona, Tucson, also found that the Tokyo Guidelines’ advice to manage grade II and grade III cholecystitis patients conservatively may be unwarranted, because there were no differences in safety outcomes between grade I and grade II patients who underwent early cholecystectomy.
The Tokyo Guidelines were based on expert opinion rather than evidence, and may be limited by differences in practices in Japan and other countries. “There was no formal evaluation of the sensitivity and specificity in any other country,” Faisal Jehan, MD, a research fellow at the University of Arizona, said in an interview. Dr. Jehan presented the study at the annual meeting of the Western Surgical Association.
The study suggests there is additional work to be done before the guidelines are more generally applicable. They are being updated and the new version is slated to appear in 2018.
Cholecystectomy is one of the most common procedures in the United States, and hence represents a major source of health care expenditure. Useful guidelines will therefore be welcome to help standardize treatment, according to Dr. Riall. “I think while we’ve moved as a population toward earlier cholecystectomy, it isn’t uniformly practiced in the United States. So I think there is value in having guidelines that are relevant to our population and relevant to our practice,” she said.
But compared with the pathology report, the TG13 guidelines fared poorly in prediction of acute cholecystitis, with a sensitivity of just 53% (definitive 27%, suspected 26%, undiagnosed 53%). The underperformance of the guidelines may be due in part to recent changes in health-seeking behavior, as patients are likely to get to the hospital more quickly than in the past, and thus exhibit fewer clinical signs when first examined. “That could be decreasing the sensitivity,” said Dr. Jehan.
Suspicious that the guidelines were inadequate, the researchers analyzed their institution’s Emergency General Surgery registry, examining records from 952 patients who presented with right upper quadrant pain between 2013 and 2015. They compared diagnoses and severity assessed using the TG13 guidelines to the ensuing pathology reports, which were obtained from patient charts.
A total of 857 patients of the 952 had biliary disease. Of these, 779 patients went on to cholecystectomy, 15 had cholecystostomy-tube placement, and 63 were managed conservatively with no surgery. Among patients with biliary disease, the frequency of fever at presentation was just 4%, while 51.8% had leukocytosis. Right upper quadrant tenderness was the most sensitive predictor of acute cholecystitis (92%). Murphy’s sign occurred in 28.8% of patients and had a 72% sensitivity.
Following the TG13 guidelines resulted in classification of 414 patients as grade I, 400 as grade II, and 43 as grade III. A total of 92.5% of grade I patients underwent early cholecystectomy, as the TG-13 guidelines suggest. Nearly as many (89.3%) grade II patients also underwent early surgery, as did 50% of grade III patients. The complication rate was similar between grade I and grade II patients who underwent surgery (3.7% vs. 4.7%; P = .81). The rate of return to the operating room was also similar (0.6% vs. 0.7%; P = .95), as was mortality (0.3% vs. 0%; P = .96).
SCOTTSDALE, ARIZ. – In patients with right upper quadrant pain, the Tokyo Guidelines (TG13) failed to detect acute cholecystitis with adequate sensitivity, according to a single institution retrospective review.
Researchers at the University of Arizona, Tucson, also found that the Tokyo Guidelines’ advice to manage grade II and grade III cholecystitis patients conservatively may be unwarranted, because there were no differences in safety outcomes between grade I and grade II patients who underwent early cholecystectomy.
The Tokyo Guidelines were based on expert opinion rather than evidence, and may be limited by differences in practices in Japan and other countries. “There was no formal evaluation of the sensitivity and specificity in any other country,” Faisal Jehan, MD, a research fellow at the University of Arizona, said in an interview. Dr. Jehan presented the study at the annual meeting of the Western Surgical Association.
The study suggests there is additional work to be done before the guidelines are more generally applicable. They are being updated and the new version is slated to appear in 2018.
Cholecystectomy is one of the most common procedures in the United States, and hence represents a major source of health care expenditure. Useful guidelines will therefore be welcome to help standardize treatment, according to Dr. Riall. “I think while we’ve moved as a population toward earlier cholecystectomy, it isn’t uniformly practiced in the United States. So I think there is value in having guidelines that are relevant to our population and relevant to our practice,” she said.
But compared with the pathology report, the TG13 guidelines fared poorly in prediction of acute cholecystitis, with a sensitivity of just 53% (definitive 27%, suspected 26%, undiagnosed 53%). The underperformance of the guidelines may be due in part to recent changes in health-seeking behavior, as patients are likely to get to the hospital more quickly than in the past, and thus exhibit fewer clinical signs when first examined. “That could be decreasing the sensitivity,” said Dr. Jehan.
Suspicious that the guidelines were inadequate, the researchers analyzed their institution’s Emergency General Surgery registry, examining records from 952 patients who presented with right upper quadrant pain between 2013 and 2015. They compared diagnoses and severity assessed using the TG13 guidelines to the ensuing pathology reports, which were obtained from patient charts.
A total of 857 patients of the 952 had biliary disease. Of these, 779 patients went on to cholecystectomy, 15 had cholecystostomy-tube placement, and 63 were managed conservatively with no surgery. Among patients with biliary disease, the frequency of fever at presentation was just 4%, while 51.8% had leukocytosis. Right upper quadrant tenderness was the most sensitive predictor of acute cholecystitis (92%). Murphy’s sign occurred in 28.8% of patients and had a 72% sensitivity.
Following the TG13 guidelines resulted in classification of 414 patients as grade I, 400 as grade II, and 43 as grade III. A total of 92.5% of grade I patients underwent early cholecystectomy, as the TG-13 guidelines suggest. Nearly as many (89.3%) grade II patients also underwent early surgery, as did 50% of grade III patients. The complication rate was similar between grade I and grade II patients who underwent surgery (3.7% vs. 4.7%; P = .81). The rate of return to the operating room was also similar (0.6% vs. 0.7%; P = .95), as was mortality (0.3% vs. 0%; P = .96).
SCOTTSDALE, ARIZ. – In patients with right upper quadrant pain, the Tokyo Guidelines (TG13) failed to detect acute cholecystitis with adequate sensitivity, according to a single institution retrospective review.
Researchers at the University of Arizona, Tucson, also found that the Tokyo Guidelines’ advice to manage grade II and grade III cholecystitis patients conservatively may be unwarranted, because there were no differences in safety outcomes between grade I and grade II patients who underwent early cholecystectomy.
The Tokyo Guidelines were based on expert opinion rather than evidence, and may be limited by differences in practices in Japan and other countries. “There was no formal evaluation of the sensitivity and specificity in any other country,” Faisal Jehan, MD, a research fellow at the University of Arizona, said in an interview. Dr. Jehan presented the study at the annual meeting of the Western Surgical Association.
The study suggests there is additional work to be done before the guidelines are more generally applicable. They are being updated and the new version is slated to appear in 2018.
Cholecystectomy is one of the most common procedures in the United States, and hence represents a major source of health care expenditure. Useful guidelines will therefore be welcome to help standardize treatment, according to Dr. Riall. “I think while we’ve moved as a population toward earlier cholecystectomy, it isn’t uniformly practiced in the United States. So I think there is value in having guidelines that are relevant to our population and relevant to our practice,” she said.
But compared with the pathology report, the TG13 guidelines fared poorly in prediction of acute cholecystitis, with a sensitivity of just 53% (definitive 27%, suspected 26%, undiagnosed 53%). The underperformance of the guidelines may be due in part to recent changes in health-seeking behavior, as patients are likely to get to the hospital more quickly than in the past, and thus exhibit fewer clinical signs when first examined. “That could be decreasing the sensitivity,” said Dr. Jehan.
Suspicious that the guidelines were inadequate, the researchers analyzed their institution’s Emergency General Surgery registry, examining records from 952 patients who presented with right upper quadrant pain between 2013 and 2015. They compared diagnoses and severity assessed using the TG13 guidelines to the ensuing pathology reports, which were obtained from patient charts.
A total of 857 patients of the 952 had biliary disease. Of these, 779 patients went on to cholecystectomy, 15 had cholecystostomy-tube placement, and 63 were managed conservatively with no surgery. Among patients with biliary disease, the frequency of fever at presentation was just 4%, while 51.8% had leukocytosis. Right upper quadrant tenderness was the most sensitive predictor of acute cholecystitis (92%). Murphy’s sign occurred in 28.8% of patients and had a 72% sensitivity.
Following the TG13 guidelines resulted in classification of 414 patients as grade I, 400 as grade II, and 43 as grade III. A total of 92.5% of grade I patients underwent early cholecystectomy, as the TG-13 guidelines suggest. Nearly as many (89.3%) grade II patients also underwent early surgery, as did 50% of grade III patients. The complication rate was similar between grade I and grade II patients who underwent surgery (3.7% vs. 4.7%; P = .81). The rate of return to the operating room was also similar (0.6% vs. 0.7%; P = .95), as was mortality (0.3% vs. 0%; P = .96).
AT WSA 2017
Key clinical point: Early surgery for acute cholecystitis appears safe in well selected patients.
Major finding: TG13 guidelines predicted acute cholecystitis with a sensitivity of 53%.
Data source: Analysis of a prospectively collected data on 952 patients at a single institution.
Disclosures: The study received no outside funding. Dr. Jehan and Dr. Riall reported having no financial disclosures.